K113551 is an FDA 510(k) clearance for the ESOPHAGEAL TTS STENT. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Taewoong Medical Co., Ltd. (Alexandria, US). The FDA issued a Cleared decision on February 14, 2012, 75 days after receiving the submission on December 1, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K113551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2011 |
| Decision Date | February 14, 2012 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ESW — Prosthesis, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |